Multiple Sclerosis (MS)NCT02612935
An Observational Pilot Study of Lumosity Computerized Cognitive Training in Subjects With Multiple Sclerosis
An observational study of Multiple Sclerosis (MS), run by Lumos Labs, Inc..
Trial summary
In collaboration with the Mercy MS Achievement Center, Lumos Labs is proposing an open-label, 12-month pilot study of computerized cognitive training as part of the cognitive wellness program in order to evaluate (1) the user experience of Lumosity in individuals with MS, and (2) the efficacy of Lumosity for improving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- Lumosity
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 50 current members of the Mercy MS Achievement Center will be provided with 12-month premium access Lumosity accounts. Study participants must be ≥18 years of age, and currently members of the Achievement Center participating in the cognitive wellness program.
Who may be able to join
- Participants must meet the following criteria:
- Signed informed consent
- 18 years of age or older,
- English-speaking,
- Current participants in the MS Achievement Center Cognitive Wellness Program
- Sufficient physical capacity to use a computer keyboard and mouse
- Willing and able to use Lumosity at least 3 times per week
Who cannot join
- Participants who meet any of the following criteria will be excluded from participation:
- Under 18 years of age
- Are taking medication that may impede cognitive functioning
- Have other conditions or problems that may preclude regular computer usage
About this study
In collaboration with the Mercy MS Achievement Center, Lumos Labs is proposing an open-label, 12-month pilot study of computerized cognitive training as part of the cognitive wellness program in order to evaluate (1) the user experience of Lumosity in individuals with MS, and (2) the efficacy of Lumosity for improving cognitive outcomes in individuals with MS.
Read the detailed description
Approximately 50 current members of the Mercy MS Achievement Center will be provided with 12-month premium access Lumosity accounts. Study participants must be ≥18 years of age, and currently members of the Achievement Center participating in the cognitive wellness program. Those who consent will be provided with an account activation code and instructed on how to sign up for Lumosity.
Upon creating an account, users would be asked to complete a short demographic survey (Information About You, which includes age, sex, race/ethnicity, education, occupation) and two additional short surveys: a Computer Experience Questionnaire and a Perceptions of Brain Training questionnaire. In addition, participants will be assessed with the Montreal Cognitive Assessment (MOCA), and be directed to take the Brain Performance Test (on a laptop or desktop computer) within the first 7 days of creating their account. If not conducted within the previous 3 months, participants would also be required to have the following assessments at baseline (i.e., within the first 7 days): Multiple Sclerosis Neuropsychological Questionnaire (MSNQ), Multiple Sclerosis Impact Scale-29 (MSIS-29), and Beck Depression Inventory (BDI). After one week of using Lumosity, and then every other month for 12 months, participants would be asked to complete a short questionnaire about their experience with Lumosity. Every 3 months, participants would repeat the BPT, MSNQ, and BDI; and every 6 months, they would repeat the MSIS. Finally, at the end of the study, the end of the study they would also repeat the MOCA.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- Lumosity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumosityDevice
Lumosity offers a suite of online games focused on stimulating cognitive domains of attention, memory, cognitive flexibility, problem solving, and speed of processing. The Lumosity program may be well suited for cognitive remediation in individuals with MS.
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Characteristics and Usability measures of Lumosity, as measured by Self-Report Descriptive Questionnaires
The primary objective is to determine performance characteristics and usability of Lumosity in individuals with MS as measured through qualitative questionnaires.
Measured: 1 year
Secondary outcomes (6)
Efficacy of Lumosity in individuals with MS, as measured with the BPT
To determine the efficacy of Lumosity in this study population as measured by change from baseline on the BPT Grand Index score and scaled subtest scores at 3, 6, 9, and 12 months
Measured: Change from baseline as measured at 3, 6, 9 and 12 months
Efficacy of Lumosity in individuals with MS, as measured with the MSNQ
To determine the efficacy of Lumosity in this study population as measured by
- Change from baseline on the MSNQ at 12 months
Measured: 1 Year
Efficacy of Lumosity in individuals with MS, as measured with the MOCA
To determine the efficacy of Lumosity in this study population as measured by
- Change from baseline on the MOCA at 12 months
Measured: 1 Year
Efficacy of Lumosity in individuals with MS, as measured with the MSIS-29.
To determine the efficacy of Lumosity in this study population as measured by
- Change from baseline on the MSIS-29 at 12 months
Measured: 1 Year
Efficacy of Lumosity in individuals with MS, as measured with the BDI.
To determine the efficacy of Lumosity in this study population as measured by
- Change from baseline on the BDI at 12 months
Measured: 1 Year
Engagement - as measured by number of unique days played and number of games played
To determine the level of engagement with Lumosity in individuals with MS as measured by number of unique days and number of games played
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dignity Health
- Responsible party
- Sponsor
- Investigators
- Brian Hutchinson, Principal investigator, MS Achievement Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612935
- Sponsor's protocol ID
- LL009 - MS ACHIEVEMENT STUDY
- Status last verified
- May 2017
- First submitted
- 19 Nov 2015
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Pilot Study of Lumosity Computerized Cognitive Training in Subjects With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02612935
- Acronym / sponsor ID
- LL009 - MS ACHIEVEMENT STUDY
- Conditions
- Multiple Sclerosis (MS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Lumos Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dignity Health
- Study start
- Mar 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In collaboration with the Mercy MS Achievement Center, Lumos Labs is proposing an open-label, 12-month pilot study of computerized cognitive training as part of the cognitive wellness program in order to evaluate (1) the user experience of Lumosity in individuals with MS, and (2) the efficacy of Lumosity for improving cognitive outcomes in individuals with MS.
Detailed description
Approximately 50 current members of the Mercy MS Achievement Center will be provided with 12-month premium access Lumosity accounts. Study participants must be ≥18 years of age, and currently members of the Achievement Center participating in the cognitive wellness program. Those who consent will be provided with an account activation code and instructed on how to sign up for Lumosity.
Upon creating an account, users would be asked to complete a short demographic survey (Information About You, which includes age, sex, race/ethnicity, education, occupation) and two additional short surveys: a Computer Experience Questionnaire and a Perceptions of Brain Training questionnaire. In addition, participants will be assessed with the Montreal Cognitive Assessment (MOCA), and be directed to take the Brain Performance Test (on a laptop or desktop computer) within the first 7 days of creating their account. If not conducted within the previous 3 months, participants would also be required to have the following assessments at baseline (i.e., within the first 7 days): Multiple Sclerosis Neuropsychological Questionnaire (MSNQ), Multiple Sclerosis Impact Scale-29 (MSIS-29), and Beck Depression Inventory (BDI). After one week of using Lumosity, and then every other month for 12 months, participants would be asked to complete a short questionnaire about their experience with Lumosity. Every 3 months, participants would repeat the BPT, MSNQ, and BDI; and every 6 months, they would repeat the MSIS. Finally, at the end of the study, the end of the study they would also repeat the MOCA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 current members of the Mercy MS Achievement Center will be provided with 12-month premium access Lumosity accounts. Study participants must be ≥18 years of age, and currently members of the Achievement Center participating in the cognitive wellness program.
Key inclusion criteria (7 listed)
- Signed informed consent
- 18 years of age or older,
- English-speaking,
- Current participants in the MS Achievement Center Cognitive Wellness Program
- Sufficient physical capacity to use a computer keyboard and mouse
Key exclusion criteria (4 listed)
- Under 18 years of age
- Are taking medication that may impede cognitive functioning
- Have other conditions or problems that may preclude regular computer usage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumosityLumosity offers a suite of online games focused on stimulating cognitive domains of attention, memory, cognitive flexibility, problem solving, and speed of processing. The Lumosity program may be well suited for cognitive remediation in individuals with MS. | Device | – |
Primary outcome
Performance Characteristics and Usability measures of Lumosity, as measured by Self-Report Descriptive Questionnaires
Time frame: 1 year
The primary objective is to determine performance characteristics and usability of Lumosity in individuals with MS as measured through qualitative questionnaires.
6 secondary outcomes
Efficacy of Lumosity in individuals with MS, as measured with the BPT
Time frame: Change from baseline as measured at 3, 6, 9 and 12 months
Efficacy of Lumosity in individuals with MS, as measured with the MSNQ
Time frame: 1 Year
Efficacy of Lumosity in individuals with MS, as measured with the MOCA
Time frame: 1 Year
Efficacy of Lumosity in individuals with MS, as measured with the MSIS-29.
Time frame: 1 Year
Efficacy of Lumosity in individuals with MS, as measured with the BDI.
Time frame: 1 Year
Engagement - as measured by number of unique days played and number of games played
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Hutchinson principal investigator
MS Achievement Center
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS), run by Lumos Labs, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Characteristics and Usability measures of Lumosity, as measured by Self-Report Descriptive Questionnaires (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.